Stopadol 650 mg 30 tablets

Stopadol 650 mg 30 tablets

Composition:

Each tablet contains:
Paracetamol 650 mg (325 mg sustained‑release layer + 325 mg immediate‑release layer).
Excipients: pregelatinized starch, polyvinylpyrrolidone, hydroxypropyl methylcellulose, sodium starch glycolate, magnesium stearate, macrogol, talc, titanium dioxide, FD&C Yellow, FD&C Blue.

Product Description:

Paracetamol is an effective analgesic and antipyretic with weak anti‑inflammatory properties.
Its action is mainly due to inhibition of prostaglandin synthesis in the CNS and modulation of the hypothalamic thermoregulatory center.
Stopadol combines immediate and sustained release layers, providing dual action, gastric safety, and pain relief lasting 6–8 hours.

Indications for Use:

• Relief of persistent pain associated with osteoarthritis, muscle pain, and back pain.
• Temporary relief of headache, cold and flu symptoms, menstrual pain, toothache, and post‑dental pain.
• Reduction of fever.

Method of Administration and Dosage:

• Adults and children ≥12 years: 2 tablets swallowed whole, three times daily every 6–8 hours.
• Maximum dose: 6 tablets in 24 hours.
• Not recommended for children under 12 years.
• Adolescents (12–17 years): do not use for more than 48 hours without medical advice.
• Tablets must be swallowed with water; do not chew. May be taken with or without food.
• Do not use with other paracetamol‑containing products.

Contraindications:

Hypersensitivity to paracetamol or any excipient.

Precautions:

• Use with caution in patients with severe hepatic or renal impairment.
• Risk of overdose is higher in patients with alcoholic cirrhosis.
• Do not exceed the stated dose.
• Seek medical advice if symptoms persist beyond 3 days.
• Immediate medical attention is required in case of overdose.
• Drug interactions:
  Cholestyramine reduces absorption rate.
  Metoclopramide and domperidone increase absorption.
  Warfarin and other coumarins: prolonged use may enhance anticoagulant effect.
  Chloramphenicol: plasma concentration may increase.

Adverse Reactions / Side Effects:

• Blood and lymphatic system: very rare — thrombocytopenia.
• Immune system: very rare — anaphylaxis, hypersensitivity skin reactions (rash, angioedema, Stevens–Johnson syndrome, toxic epidermal necrolysis).
• Respiratory system: bronchospasm in aspirin/NSAID‑sensitive patients.
• Gastrointestinal system: very rare — impaired liver function.

Pregnancy and Lactation:

Pregnancy: epidemiological studies show no adverse effects at recommended doses, but use only under medical advice.
Lactation: paracetamol is excreted in breast milk; may be used if clearly necessary and prescribed by a physician.

Storage Conditions:

Store at temperatures not exceeding 30 °C, in a dry place, protected from light.

Packaging:

Carton box containing 3 blisters of 10 tablets and a leaflet.